About
SA Quality Solutions delivers turnkey remote QMS audit services - helping medical-device and IVD companies navigate FDA QSR, ISO 13485, EU MDR & MDSAP with zero travel. • 300+ audits completed since 2015 across OEM, IVD, SaMD and contract-manufacturing clients • Specialty in EU MDR & IVDR gap assessments, MDSAP implementation, CAPA & risk-management workshops Ready to launch your next remote audit or gap analysis? Message us to schedule a free 30-min mini-audit call.
Technologies
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Keywords
certification
internal audits
mock audits
eu mdr
implementation
training
quality management system development
gap audits
registration & listing
risk management
compliance & remediation
regulatory strategy mdsap
ukca
supplier audits
medical equipment manufacturing
medical devices
hospital & health care
Company Information
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Employees 1
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Founded 2022
Location
West Palm Beach, Florida, United States